MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA; SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA ELITION S
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a report that the patient suffered burns (2nd degree) with blistering to each hand following the lumbar spine examination.A small blister over the knuckle of the thumb of the right hand and on the index finger of the left hand was visible in the provided image.
Additional Manufacturer Narrative
There is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The patient received burns (2nd degree) with blistering to each hand following the lumbar spine examination.A small blister over the knuckle of the thumb of the right hand and on the index finger of the left hand was visible in the provided image.The injuries most likely occurred due to contact at the base of the patient¿s right hand thumb and the left hand index finger.No padding was used to prevent this from occurring.The patient was provided cooling with no other medical intervention required and is expected to fully recover.The injuries, 2nd degree burns to each hands, are consistent with heating incidents caused by insufficient distance between body parts, a so-called skin-to-skin burn.

• Brand Name: INGENIA
• Common Device Name: SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 20795380
• Report Number: 3003768277-2024-006854
• Device Sequence Number: 15405958
• Product Code: LNH
• UDI-Device Identifier: 00884838098329
• UDI-Public: (01)00884838098329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: INGENIA ELITION S
• Device Catalogue Number: 782106
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 120 KG